Coreva Health Science LLC recalls ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5cm X 5cm) 4in X 4in Sterile Contents Soluble R…

Recall date

May 18, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1697-2015

FDA classification

Class II

Brand / firm

Coreva Health Science LLC

Sold / distributed

U.S. distribution to the following; TX, NY, FL, VA, WA, and AZ. No foreign distribution. NOTE: The distribution list the firm provided does not include all consignees that purchased the product; rather target the consignees (distributors) who were observed to be using an unapproved marketing use.

Why it was recalled

Coreva Health Science, LLC. is recalling ActCel Hemostatic Dressing due to customer literature and web sites promoting that it can help control bleeding from open wounds and in body cavities. ActCel is indicated as a prescription device for management of topical wounds and to temporarily control external surface bleeding.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5cm X 5cm) 4in X 4in Sterile Contents Soluble Regenerated Cellulose For Bleeding Control For external topical and temporary use only Sterility of contents guaranteed unless individual envelope is damaged or opened. Store at room temperature (41F-104F). Do not autoclave.